Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Improvement in headache frequency and pain degree among participants
研究概览
简要总结
The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.
详细描述
Chronic headache is a common symptom in children. Pharmacologic treatment has only a limited productivity and several known adverse reactions. Despite the frequency and chronicity of pediatric headache, validated treatment paradigms are currently inadequate.
Biofeedback is a medical treatment in which physiologic markers like heart rate, breathing rate, EMG, EEG, or electrodermal activity are measured and displayed back to the patient. The patient can then attempt to modulate physiology to achieve a certain feedback goal,such as slowing heart or breath rate, or relaxing certain muscles. Numerous psychophysiologic studies have been conducted that examine the effect of biofeedback alone on physiology as well as various clinical conditions. Clinical trials for chronic headaches have found that biofeedback was more effective in the treatment of headache when compared to pure drug therapy.
A number of recent distraction interventions for acute pain in children and adolescents have employed virtual reality technology in conjunction with either a passive distraction stimulus, such as a movie, or an interactive distraction activity, such as a computer game. However, the actual benefit of VR technology over and above the benefits of the distracting stimulus that is experienced through the VR equipment has not been adequately tested in children.
The objective of this study is to combine virtual reality with biofeedback in order to increase the effectivity of both techniques in decreasing chronic headache frequency and pain degree in the pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •9-18 years old children suffering from chronic headache diagnosed by pediatric neurologist
- •Exclusion of Other disorders causing chronic headache
排除标准
- •Children younger than 9 years or olde than
- •Children who do not fulfill headache criteria as described in the International Headache Society
- •Children who were not examined by a certified pediatric neurologist
结局指标
主要结局
Improvement in headache frequency and pain degree among participants
时间窗: 6 weeks
次要结局
未报告次要终点
